 HIP

Increased incidence of femoral fractures in small femurs and women undergoing uncemented total hip arthroplasty – why? M. P. Bonnin, C. C. Neto, T. Aitsiselmi, C. G. Murphy, N. Bossard, S. Roche From Centre Orthopédique Santy, Lyon, France

The aim of this study was to investigate the relationship between the geometry of the proximal femur and the incidence of intra-operative fracture during uncemented total hip arthroplasty (THA). We studied the pre-operative CT scans of 100 patients undergoing THA with an uncemented femoral component. We measured the anteroposterior and mediolateral dimensions at the level of division of the femoral neck to calculate the aspect ratio of the femur. Wide variations in the shape of the femur were observed, from round, to very narrow elliptic. The femurs of women were narrower than those of men (p < 0.0001) and small femurs were also narrower than large ones. Patients with an intra-operative fracture of the calcar had smaller and narrower femurs than those without a fracture (p < 0.05) and the implanted Corail stems were smaller in those with a fracture (mean size 9 vs 12, p < 0.0001). The variability of the shape of the femoral neck at the level of division contributes to the understanding of the causation of intra-operative fractures in uncemented THA. Cite this article: Bone Joint J 2015;97-B:741–8.

 M. P. Bonnin, MD, Orthopaedic Surgeon  C. C. Neto, MD, Orthopaedic Surgeon  T. Aitsiselmi, MD, Orthopaedic Surgeon  C. G. Murphy, MD, Orthopaedic Surgeon Centre Orthopédique Santy, 24 Av Paul Santy, 69008 Lyon, France.  N. Bossard, MD, PhD, Statistician  S. Roche, MSc, Statistician Hospices Civils de Lyon, F-69003 Lyon, France. Correspondence should be sent to Dr M. P. Bonnin; e-mail: [email protected] ©2015 The British Editorial Society of Bone & Joint Surgery doi:10.1302/0301-620X.97B6. 35022 $2.00 Bone Joint J 2015;97-B:741–8. Received 25 August 2014; Accepted after revision 21 January 2015

VOL. 97-B, No. 6, JUNE 2015

The rate of intra-operative femoral fractures1-4 during primary uncemented total hip arthroplasty (THA) ranges from 0.1%5 to 11%.6 Most fractures originate in the area of the calcar, and may extend distally.1,7-9 Although many factors contribute to the cause of these fractures, including the design of the stem and the surgical technique, they are ultimately induced by a mismatch either between the broach or the implant and the bone. This mismatch occurs predominantly at either the area of division of the femoral neck or in the metaphysis.8 The risk of intra-operative fracture with uncemented components has been reported to be higher in women10-13 and in patients with dysplastic femurs,14 but there has been no previous attempt to describe the influence of the geometry or size of the femur.6,11 Using data from the National Joint Registry for England and Wales, Jameson et al15 also reported a higher rate of revision for small sizes of stem with the Corail hip prosthesis (DePuy, Warsaw, Indiana) (size 8 to 10), at a maximum followup of 7.5 years. They observed that 10.5% of all revisions were due to fractures of the femur, and suggested that “patients requiring smaller stems may be less suitable for cementless THR.”15 We hypothesised that firstly, smaller femurs have a proportionate, or disproportionate,

geometrical difference to large femurs at the level of the division of the femoral neck and secondly, that the femurs that fracture have a different geometry to those that do not, and thirdly that femurs requiring a smaller Corail stem are more likely to fracture. To our knowledge, no morphometric analysis has been undertaken of the level that the femoral neck is divided during THA. Most geometric analyses of the proximal femur have been done in the coronal, sagittal or axial planes, which do not reflect the surgical reality of THA.6,16-18 In practice, regardless of the technique, after the femoral neck is divided, the appropriate broach and size of stem is dictated by the size and shape of the opening of the femur.16-18 This study was designed to describe the shape and size of the femur in the plane of the standard division of the femoral neck at THA and, therefore, to assess our three hypotheses.

Patients and Methods During 2012, 430 consecutive primary uncemented THAs were implanted in our centre. All patients had pre-operative CT scans of the hip as part of our pre-operative planning protocol.19 Data for all our patients were prospectively recorded in an institutional database. A subgroup of 100 patients was selected, comprising the first 50 consecutive THAs in 741

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M. P. BONNIN, C. C. NETO, T. AITSISELMI, C. G. MURPHY, N. BOSSARD, S. ROCHE

Fig. 1 Coronal plane CT image of the proximal femur in the long axis of the femur and femoral neck. FO, femoral offset; NL, neck length; ML, mediolateral diameter of the femoral canal at the level of the lesser trochanter (MLLT) and 5 cm and 10 cm below the lesser trochanter (ML5 and ML10).

men and women; there were 21 right hips in men and 33 in women. Exclusion criteria included previous hip surgery, previous ipsilateral fracture of either the hip or femur, an inflammatory arthropathy or osteoarthritis (OA) secondary to Crowe III or IV dysplasia.20 The mean age was 65.4 years (24 to 85) in the men and 69.4 years (50 to 86) in the women. Pre-operatively, all patients were scanned with a 64-slice multidetector scanner (Siemens Sensation, Munich, Germany) in the supine position, with their knees fully extended and legs fixed in neutral rotation. The hip joint was scanned from the anterior inferior iliac spine to 10 cm below the lesser trochanter. The mean Dose-Length Product was 1200mGy.cm.21,22 We used image-processing software dedicated to Digital Imaging and Communications in Medicine (DICOM) images (OsiriX software Pixmeo SARL, Bernex, Switzerland) to generate threedimensional (3D) reconstructions,23 on which we digitised the deepest point of the piriform fossa and the apex of the lesser trochanter.24,25 We then created two adjusted planes. The femoral plane was modified from the coronal plane in order to include the axes of the diaphysis and the femoral neck. From this plane we measured the neck inclination angle (NI), the femoral offset (FO) and the femoral neck length (NL). We also measured the mediolateral dimensions of the endosteal canal at three levels: the apex of the lesser trochanter (MLLT) and 5 cm and 10 cm below the lesser trochanter (ML5 and ML10) (Fig. 1). We defined the canal-flare index (CFI)16,18 as the ratio between MLLT and ML10. The plane of division of the femoral neck was obtained from the axial plane, inclined by 45° around an axis orthogonal to the femoral plane and including the piriform fossa. This

Fig. 2a

Fig. 2b CT image of a) small ellipse extending laterally to the piriformis fossa and b) large ellipse extending laterally to the lateral cortex of the greater trochanter. Piriformis fossa, red arrow; D, long axis; d, short axis.

plane corresponds to the plane of the division of the femoral neck. In order to analyse the shape of the femur at the level of division, we adjusted two ellipses to match the inner cortex of the femoral neck.26,27 The ‘small ellipse’ extends laterally to the piriform fossa and the ‘large ellipse’ to the lateral cortex of the greater trochanter. From the two ellipses, we measured the long axis (D), the short axis (d) and the aspect ratio, which is defined as the ratio between them (D/d) (Fig. 2). We characterised the shape of the femoral neck at this level with the aspect ratio and calculated the surface area of both ellipses using the software described. In order to investigate the influence of the level of division of the femoral neck, we reconstructed two further planes, one 5 mm more proximal to the piriform fossa (-5 mm) and one 5 mm distal (5 mm). We measured the small and large ellipse within these planes (Fig. 3). The -5 mm plane was at the level of the tip of the greater trochanter, so we could only assess the small ellipse at this level. The 5 mm plane THE BONE & JOINT JOURNAL

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Mann–Whitney test. The relationship between the aspect ratio of the ellipses and features of the femur and age were investigated with Spearman correlation coefficients. Multiple linear regression models were used to analyse the factors influencing the aspect ratio of ellipses with four variables, including gender, NI, FO and CFI. Five methods were used to cover different assumptions and features of multiple testing, but only the Bonferroni correction31,32 was reported in the manuscript and the tables. Statistical analysis used Stata software (Stata Corp LP, College Station, Texas). All tests were two-tailed and statistical significance was considered at p < 0.05.

Fig. 3 CT image showing how measurements were made at three neck-cut levels: one at the level of the piriformis fossa (red point), one 5 mm more proximal (-5 mm plane) and another 5 mm more distal (5 mm plane).

was below the piriform fossa, thus, we could only assess the large ellipse at this point. The CT software calculated the surface area of the ellipse. In order to check the consistency in the measurement of the short and long axes we recalculated the area of the ellipse (area = D/2 × d/2 × π) and verified that it was matched with the area automated from the CT software. All operations were undertaken through a posterior approach with the patient in the lateral decubitus position. We used a compaction broaching technique28-30 and the Corail uncemented femoral component (DePuy) which ranges from size 8 to size 20. The level of division of the femoral neck and the offset were determined at pre-operative planning. The goal when broaching was to obtain primary stability, both in translation and rotation. Following the use of a calcar reamer, a collared component was used except when the high offset option was used, as this is only available as collarless. The mean size of the component was 12 (8 to 16). Post-operatively, all patients were allowed to bear weight immediately without restriction, and radiographs confirmed all of the stems were well aligned. No stems migrated during the one-year follow-up period and none have been revised to date. From our initial cohort of 430 THA, we identified all the patients with an intra-operative fracture; 12 women and one man. All underwent operation for primary OA and all fractures were Mallory Type 1 calcar fractures5 that occurred during broaching. The study had ethical approval and all patients gave informed consent. Statistical analysis. We compared the morphometric criteria of the men and women using the Student’s t-test. For comparison between the groups, we used the non-parametric VOL. 97-B, No. 6, JUNE 2015

Results The dimensions of the area at the division of the femoral neck showed marked inter-individual variation. Mean values were significantly greater in men for all measurements except NI. (Tables I and II). The aspect ratio of the surface at this level for both the short and large ellipses showed wide variation among individuals, some having a ‘round aspect’ and others a ‘narrow aspect’ (Fig. 4). The mean aspect ratio was 2.2 for the large ellipse (1.8 to 2.8) and 1.6 for the small ellipse (1.3 to 2.3). The mean aspect ratio was significantly different between men and women. ‘Round’ surfaces were more common in men, while ‘narrow’ surfaces were more common in women. In total, 12 women (24%) versus one man (2%) had a ratio superior or equal to 2.4 for the large ellipse; 9 women (18%) but no men had a ratio superior or equal to 1.9 for the small ellipse (Fig. 4). At the level of the lesser trochanter, femurs that were larger in the ML dimension had smaller aspect ratios (round aspect) while those that were smaller in this dimension had greater aspect ratios (narrow aspect). The Spearman correlation between the aspect ratio of the neck and MLLT was r = -0.27, p = 0.0074 for the small ellipse and r = -0.26, p = 0.0104 for the large ellipse. Similarly, when a small size of stem was used, the section of the neck was narrower for the short and large ellipse (r = -0.32, p = 0.0012 and r = -0.40, p < 0.0001, respectively) (Fig. 5). With multiple regression analysis, the factors associated with the aspect ratio of the neck were gender, NI and CFI. Patients with coxa vara, low CFI or cylindrical femurs had rounder necks (Table III). At the -5 mm plane, the aspect ratio was greater (more narrow necks) than at the level of the piriform fossa (1.7; standard deviation (SD) 0.2 vs 1.6; SD 0.2; p < 0.0001). At the 5 mm plane the aspect ratio was lower (more round necks) than at the level of the piriform fossa (1.9; SD 0.2 vs 2.2; SD 0.2; p < 0.0001). At these levels, women had narrower necks than men (p < 0.0001). A high correlation was observed between the aspect ratios at the level of the piriform fossa and the 5 mm level (r = 0.871, p < 0.0001) as well as the -5mm level (r = 0.883, p < 0.0001) (Fig. 6, Table IV). At the level of division of the femoral neck, patients with an intra-operative fracture of the calcar had smaller and narrower femurs compared with those without a fracture

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M. P. BONNIN, C. C. NETO, T. AITSISELMI, C. G. MURPHY, N. BOSSARD, S. ROCHE

Table I. Morphometric characteristics of the femurs

Neck inclination (°) Femoral offset (mm) Neck length (mm) MLLT (mm) ML5 (mm) ML10 (mm)

Series (n = 100)

Men (n = 50)

Mean (SD) 130.1 (6.1) 44 (6) 57.8 (5.8) 28.2 (3) 13.8 (2) 11.1 (2)

Mean 129.2 46.9 60.9 29.9 14.8 12.1

Range 112 to 144 31 to 59 43 to 74 21 to 36 9 to 21 7 to 20

Women (n = 50) Range 116 to 141 38 to 58 52 to 74 21 to 36 11 to 21 8 to 20

Mean 131 41 54.6 26.4 12.8 10

Range 113 to 144 31 to 59 43 to 67 21 to 31 9 to 18 7 to 13

p-value* 0.9 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001

*Student’s t-test between females and males corrected using the Bonferroni method ML, mediolateral

Table II. Dimensional characteristics of the large and the small ellipse at the level of the piriform fossa

Large ellipse

Small ellipse

Area (cm2) Short axis (mm) Long axis (mm) Aspect ratio (D/d) Area (cm2) Short axis (mm) Long axis (mm) Aspect ratio (D/d)

Series (n = 100)

Men (n = 50)

Mean (SD)

Range

Mean

Range

Mean

Women (n = 50) Range

p-value*

10.8 (2) 25.2 (3) 54.2 (4) 2.2 (0.2) 7.2 (2) 23.6 (3) 38.3 (4) 1.6 (0.2)

6.8 to 15.9 18 to 38 42 to 63 1.8 to 2.8 4.4 to 10.5 16 to 31 29 to 47 1.3 to 2.3

12.4 27.4 57.3 2.1 8.3 25.9 40.7 1.6

9.7 to 15.9 22 to 33 50 to 63 1.8 to 2.5 6.2 to 10.5 21 to 31 34 to 47 1.3 to 1.8

9.2 23 51 2.2 6.1 21.3 36 1.7

6.8 to 12.3 18 to 28 42 to 58 1.8 to 2.8 4.4 to 8 16 to 26 29 to 43.1 1.4 to 2.3

< 0.0001 < 0.0001 < 0.0001 0.0106 < 0.0001 < 0.0001 < 0.0001 0.0063

*Student’s t-test between females and males corrected with the Bonferroni method

(Fig. 7). In those with a fracture, the mean aspect ratio for the large ellipse was 2.4 (SD 0.3; 2 to 2.8) whereas in those without a fracture it was 2.2 (SD 0.2; 1.8 to 2.5; p = 0.004). For the small ellipse, it was respectively 1.8 (SD 0.3; 1.4 to 2.3) and 1.6 (SD 0.15; 1.3 to 2; p < 0.017). In patients with a fracture of the calcar, the mean surface area of the ellipse was significantly smaller (p < 0.0001) and the size of stem was smaller, with a mean size of 9 (8 to 13) in comparison with 12 (9 to 16) in those without a fracture (p < 0.0001).

Discussion We found a wide variation in the shape of the bone at the level of division of the femoral neck, and that women have narrower femurs. Patients with an intra-operative fracture had a narrower femur and a smaller size of stem than those without a fracture. These results confirm our hypotheses and are in accordance with the results reported by Jameson et al.15 We suggest, then, that there are a number of reasons why hips in patients requiring small sizes during THA are more likely to fail. One reason for the increased rate of intra-operative fracture is that, regardless of the design of the stem, broaches and stems increase in size at an incremental, but not proportionate, rate. The relative increase in size is greater for smaller stems than for larger stems. The surgeon’s fear of inducing a fracture in patients with narrow necks may lead to another potential cause of failure including a lack of prosthetic integration as the stem may

be undersized, or inadequate compaction of bone when broaching. A further reason for failure is instability; potentially caused by the unrecognised distal extension of an intra-operative fracture. This study has limitations. Firstly, none of the CT-created ellipses exactly match the opening of the bone through which the stem is introduced. When we first tested our hypotheses, we attempted to perform intra-operative measurements using calipers, but abandoned this due to a lack of reliability. Analysis of CT scans using the ellipse technique has been previously validated26,27 and CT-measurement permits millimetric measurements. In this study, we referenced the plane of the division of the femoral neck to the piriform fossa, which is easy to locate on CT scans and is a landmark commonly used in THA.25,33 However, the level of insertion of the stem, and, therefore, the level of division of the femoral neck, can vary depending on the local anatomy, the surgical technique and the design of the stem. Indeed in practice, this area has no real lateral limitation. The elliptical shape of the femoral neck has been described previously by Zebaze et al,34 but they measured the external contour of the neck at its middle portion. They reported a mean aspect ratio of the neck of 1.33 (1.16 to 1.56) with a more elliptical shape at its base than at its mid zone. They found that the external necks of smaller femurs were less elliptical (more round), which differs from our observations of the internal neck. Our data also show that the THE BONE & JOINT JOURNAL

INCREASED INCIDENCE OF FEMORAL FRACTURES IN SMALL FEMURS AND WOMEN UNDERGOING UNCEMENTED THA

Number of hips

Females Males

15 15

15 11

10 10

10

6 5

4

745

7

6

5

4

4 2

1

0

0 1.3

1.4

1.5

1.6

1.7

1.8

0

1.9

2

Long/small diameter Fig. 4a

Number of hips

15

13 10

10

8

7

9

Females Males 12

8 6

5

4 2

7

6 4

2 0

0 1.9

1.8

2

2.1

2.2

2.3

2.4

1 2.5

1

0

2.6

Long/small diameter Fig. 4b Histograms showing the distribution of the aspect ratio in males and females with a) a small ellipse and b) a large ellipse. The value under each bar is the lower boundary of the class of aspect ratio value.

Aspect-ratio of the small ellipse

2.4 2.2 2 1.8 1.6 1.4 8 to 9

10

11

12

13

14 to16

Corail prosthesis size Fig. 5 Boxplots showing the mean aspect ratio of the small ellipse for each implanted stem size.

shape of the femoral neck at the level of division is narrower when it is divided more proximally. We could argue that the variations we observed in the aspect ratio of the neck are due to fluctuations in the level of division. However, the piriform fossa was a reliable landmark on the CT scans and the variation in the aspect ratio at all three levels (piriform fossa, -5 mm and 5 mm) would oppose this argument. VOL. 97-B, No. 6, JUNE 2015

In clinical practice, the shape at the level of the division cannot be evaluated pre-operatively with standard radiographs, making it impossible to predict the individual risk of fracture. We tried to correlate the aspect ratio of the femoral neck with parameters accessible pre-operatively and found that a narrow ellipse was more likely in women and those with a small femur, a varus neck or a cylindrical

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M. P. BONNIN, C. C. NETO, T. AITSISELMI, C. G. MURPHY, N. BOSSARD, S. ROCHE

Table III. Multiple regression analysis: relationship between the aspect ratio of the neck–cut plane and patient characteristics (n = 100) Small ellipse Gender Neck inclination Femoral offset Canal flare index

Regression coefficient -0.117 -0.049 -0.025 -0.073

p-value 0.003 0.009 0.24 0.064

Regression coefficient -0.118 -0.041 -0.035 -0.091

p-value 0.010 0.063 0.164. 0.050

PF

PF

35

30

5 mm proximal to PF

30 Number of patients

Number of patients

40

Large ellipse

25 20 15 10 5

5 mm proximal to PF

25 20 15 10 5 0

0 1.3

1.4 1.5

1.6

1.7

1.8

1.9

2

2.1

2.2 2.3

1.5 1.6 1.7 1.8 1.9 2

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

(Aspect-ratio) Long axis / small axis

(Aspect-ratio) Long axis / small axis Fig. 6a

Fig. 6b

Histograms comparing the distribution of the aspect ratio at different neck-cut levels showing a) a small ellipse aspect ratio at the level of the piriform fossa (PF) (black) and the -5 mm plane (shaded) and b) a large ellipse aspect ratio at the level of the PF (black) and the 5 mm plane (shaded).

Table IV. Dimensional characteristics of the small and large ellipse 5 mm distal and -5 mm proximal to the plane of the piriform fossa

Large ellipse 5 mm plane

Small ellipse -5 mm plane

2

Area (cm ) Short axis (mm) Long axis (mm) Aspect ratio (D/d) Area (cm2) Short axis (mm) Long axis (mm) Aspect ratio (D/d)

Series (n = 100)

Men (n = 50)

Mean (SD)

Women (n = 50)

Range

Mean

Range

Mean

Range

p-value*

12.4 (2) 28.2 (3) 55 (4) 1.9 (0.2) 6.5 (1) 22 (3) 37 (3) 1.7 (0.2)

7.5 to 19.6 20 to 40 44 to 64 1.5 to 2.5 3.7 to 10 16 to 30 27 to 47 1.3 to 2.2

14.5 31 59 1.9 7.7 24.5 39.6 1.6

11 to 19.6 25 to 40 53 to 64 1.5 to 2.2 5.7 to 10 19 to 30 34 to 47 1.3 to 2

11 26 53 2 5.7 20 35 1.8

7.6 to 16 20 to 35 44 to 61 1.5 to 2.4 3.7 to 7.2 16 to 24 27 to 42 1.4 to 2.2

< 0.0001 < 0.0001 < 0.0001 0.0002 < 0.0001 < 0.0001 < 0.0001 < 0.0001

* Difference between males and females (Student’st-test)

femur. In such specific situations, in order to avoid an intraoperative fracture it would be reasonable to have a tapered cemented stem available. Other parameters such as age, NL and FO were not statistically correlated to the aspect ratio of the femoral neck. The mechanism of causing a femoral fracture is not necessarily the same with all stems or in all patients.8 Our conclusions concerning the risk factors using the Corail stem may not extend to other commercially available stems. The long-term fixation of uncemented stems requires osteointegration, which is only obtained in the presence of good

primary stability with minimal micromotion.8,35 Stability can be obtained through mediolateral cortical contact in flat stems, full peripheral cortical contact in a metaphysealfit design or through a bed of compacted cancellous bone in stems such as the Corail.8,28-30 In our series, fractures were exclusively observed in patients with a narrow femur. This supports a wedge-effect mechanism of inducing a fracture, rather than a direct impact on the medial aspect of the calcar. It may be that single wedge flat prostheses with their greater aspect ratio are more suitable for small and narrow femurs.8,15,36 Berend and Lombardi11 decreased their rate THE BONE & JOINT JOURNAL

INCREASED INCIDENCE OF FEMORAL FRACTURES IN SMALL FEMURS AND WOMEN UNDERGOING UNCEMENTED THA M. P. Bonnin and T. Aitsiselmi have received royalties from DePuy.

35

The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.

No fracture 30

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Fracture

Small axis (mm)

This article was primary edited by E. Moulder and first proof edited by J. Scott.

25

References

20

15

10 25

30

35

40

45

50

Long axis (mm) Fig. 7 Scatterplot showing the relationship between the long and small diameter (x and y axes) of the small ellipse in the non-fractured and fractured femurs. The circle represents non-fractured femurs, the square, fractured femurs.

of fracture of the calcar from 4.4% in 1320 hips to 0.4% in 457 hips when they switched from metaphyseal-filling to single-wedge flat stems.14 On the other hand, stabilisation of such a flat stem relies on a press-fit between the medial and lateral cortices, which can be challenging in osteoporotic femurs or in larger round femurs. In such a situation, an intra-operative fracture might occur due to direct impact on the medial cortex. This study shows a low rate of intra-operative femoral fracture with the Corail stem and does not support a change of clinical practice in patients with smaller femurs. However, it does emphasise that the variation of the shape of the femur at the level of division of the femoral neck is more important than expected and may, in part, explain the increased risk of intra-operative fracture in uncemented THA. Patients with narrow necks have a higher risk of fracture and require careful and delicate broaching. These findings are relevant when considering the design of the femoral component for THA and suggest a role for tailoring stems to gender, as well as altering the proximal aspect ratio of smaller stems to ensure proportionality. Supplementary material A description of the methods used to address the multiple testing issues and tables showing the corrected p-values are available alongside the online version of this article at www.bjj.boneandjoint.org.uk. Author contributions: M. P. Bonnin: Performed surgeries, Main investigator, Data analysis, Writing the paper. C. C. Neto: Data collection, Data analysis. T. Aitsiselmi: Performed surgeries, Data collection. C. G. Murphy: Writing the paper. N. Bossard: Data analysis, Statistical analysis. S. Roche: Statistical analysis. VOL. 97-B, No. 6, JUNE 2015

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Increased incidence of femoral fractures in small femurs and women undergoing uncemented total hip arthroplasty - why?

The aim of this study was to investigate the relationship between the geometry of the proximal femur and the incidence of intra-operative fracture dur...
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